BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 14574673 · Received June 2, 2022

    Report

    Report Number
    3006630150-2022-02650
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    September 28, 2021
    Report Date
    June 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7072560.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION CAUSED BY LEAD MIGRATION OF BOTH LEADS WHICH WAS CONFIRMED BY IMAGING. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH AN ATTEMPT TO REPOSITION THE LEADS WAS MADE BUT DUE TO SCAR TISSUE WAS NOT POSSIBLE. THE PHYSICIAN DECIDED TO EXPLANT ALL DEVICES. THE DEVICES WERE NOT RETURNED TO FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197796 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7070646 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention